Apparatus for introducing intraosseous portals

ABSTRACT

Apparatus are disclosed for intraosseous fluid infusion or aspiration of bone marrow of a subject. Particular apparatus include a bone portal (bone-penetrating member) comprising axially-aligned distal and proximal sections. The proximal section extends in a distal direction from a proximate end of the bone portal and the distal section extends in the distal direction from the proximate section to a distal end of the bone portal. The bone portal also comprises a fluid-transport bore extending between a proximal opening in the proximal section and a distal opening in the distal section. At least a portion of the distal section has a cross-sectional area, perimeter, diameter and/or dimension greater than that of the proximal section.

RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.12/012794 filed 5 Feb. 2008, which is a continuation of U.S. patentapplication Ser. No. 10/860046 filed 4 Jun. 2004 and entitled PATCH FORLOCATING A TARGET ZONE FOR PENETRATION which itself is a division ofU.S. patent application Ser. No. 09/423,855 filed 2 Mar. 2000 andentitled METHOD AND APPARATUS FOR INTRAOSSEOUS INTRODUCTION OF A DEVICESUCH AS AN INFUSION TUBE.

FIELD

The present invention relates to apparatus for infusing liquids into andto the aspiration of the bone marrow from humans and animals. Particularembodiments provide bone-penetrating members for use in such apparatus.

BACKGROUND OF THE INVENTION

Usually drugs and liquids are delivered to patients through a catheteror intravenously in a peripheral blood vessel. This method issatisfactory in cases where the blood pressure of the patient is atnormal levels. However, when blood pressure drops, for example, during aheart attack, drug overdose, or severe hemorrhaging, the peripheralblood vessels collapse and access to these vessels is difficult orimpossible. In such cases, an alternative to intravenous infusion isintraosseous infusion. An intraosseous infusion apparatus may be used toinfuse drugs and other liquids into the bone marrow under such emergencyconditions. In particular, an intraosseous device is used to penetratethe patient's skin, the subcutaneous layer between the skin and the topof the cortical layer of the bone, the cortical layer of the bone, andthe bone marrow, and to supply drugs or fluids directly to the bloodsupply system of the bone. Typically, the sternum, femur, tibia or otherbone near the skin is used. Intraosseous infusion can also be used onpatients with blood vessels that are hard to find and on young childrenwhose blood vessels are small and also hard to find. Intraosseousinfusion can also be used in emergency or battlefield conditions wherequick intravascular access may make the difference between life anddeath. The caregivers in these situations have low levels of trainingand need an intraosseous device that is simple and rapid to use.

Although intraosseous infusion is a feasible alternative tointravascular infusion, it has not met with widespread acceptance andpopularity for a variety of reasons. One reason for this is thepractical difficulty in inserting the infusion needle to the properdepth in the bone in order to access the marrow. One method to overcomethis problem has been to use a stop or marker on the needle to indicatewhen the needle has penetrated to a particular depth. This method hasnot been effective since it requires an estimation of the required depthand careful control during advancement of the needle. Skin and tissuethickness overlying the bone range from 3 mm to 30 mm and thus the skinsurface cannot be used as a reliable reference point. A trainedindividual like a doctor would be needed to determine the correct depthand insert the intraosseous device. This can be difficult even forhighly skilled professionals. Another method to overcome this problemhas been to monitor the resistance to the penetration of the infusionneedle. The resistance is high when the needle goes through the corticallayer of the bone but decreases when it hits the bone marrow. Thismethod is not very effective since resistances may vary. Again, a highlytrained individual is required to advance the intraosseous needle ortube slowly and feel for the changes in resistance.

Intraosseous penetration of the cortical layer of the bone to the bonemarrow is also needed when a sample of bone marrow from a patient mustbe taken. Again a needle or tube must be inserted through thesubcutaneous layer into the bone so that the bone marrow can then beaspirated. Again, only a highly trained individual can accuratelydetermine the depth of the penetration of the tube or needle into thebone marrow.

In U.K. Pat. No. 1,315,796, issued to Pashenichny et al., a device forintraosseous injection is disclosed consisting of an outer tube with ascrew and a male thread on one end and an inner tube fitted into theouter tube. The device is drilled into the osseous tissue, the innertube is removed and a cannula is connected to the outer tube. U.S. Pat.No. 4,969,870, issued to Kramer et al., discloses an apparatus forintraosseous infusions having a base positioned with its lower surfaceagainst the patient's skin and the infusion tube is pushed through theskin and then rotated to thread through the bone until continuedrotation of the tube no longer advances the tube. In both of thesedevices, there is no automatic depth sensing mechanism. In U.S. Pat. No.3,815,605, issued to Schmidt et al., an intraosseous device has pins orlegs similar to a bone probe that penetrates through the subcutaneouslayer. The user releases a compressed spring that exerts a force on anddelivers energy to a striker pin to cause it to penetrate the bone. Astriker-pin holder that couples the spring to the striker pin engages ashoulder, which houses the bone probe, thereby limiting the penetrationof the striker pin into the bone. Once the spring is released there isno user control over force applied to the striker pin. Thus, if thespring force is insufficient to penetrate the bone cortical the devicebecomes inoperative. Although this device does have a bone probe whichallows the bone cortical layer to be used as a reference point indetermining the depth of the penetration of the striker pin instead ofthe skin, there is no automatic release mechanism to preventover-penetration of the bone marrow by the coupling member. When thestriker-pin holder engages the shoulder, the excess energy released fromthe spring may drive the coupling member downwardly and over-penetratethe bone.

U.S. Pat. No. 5,520,650 issued to Zadini discloses a device forinserting a cannula into a body cavity. A piston is pushed by hand sothat an attached cannula penetrates the skin. Once well under the skinthe operator releases the piston and the piston is urged to return by aspring bias creating a vacuum in the piston chamber. The vacuum drawsbody fluid into the cannula and piston chamber until the vacuum drops.With the vacuum low enough, the piston moves back against an arrest pinreleasing an interface member to be urged forward by a spring causing anarrest rod to be locked which, in turn blocks further movement of thecatheter or needle. Zadini requires a hollow cannula be inserted sinceit senses pressure in order to hold the cannula from causing the chainof events that locks an arrest rod and prevents further insertion of thehollow cannula. The needle tip is expected to encounter a fluid whichwill flow into the needle, destroying the vacuum in the chamber andallow the piston to move, thus triggering the arrest mechanisms of thedevice. Zadini also requires that the overlying tissue have sealingqualities. Thirdly, Zadini arrests movement of the cannula immediatelyupon entry into a suitable body cavity and does not detect relativeposition within a target cavity, but merely whether the cannula is inthe cavity or not.

U.S. Pat. No. 4,874,380 issued to Hesketh discloses a releasablecatheter retaining device mounted on a patch which has a post to whichis anchored a cable tie. The cable tie is used to engage a catheter. Thesole function of the patch is to retain a catheter.

Battenfield discloses a template for instructing proper insertion of ameans for draining a distended bursa. The template is for use on eithera right or left knee and has locating indicia marked on it for visualalignment with the patella and tibia. Since visual alignment alone isunreliable it would be desirable to combine such a method with a moremechanical method of alignment.

Other similar apparatus for intravascular infusion (U.S. Pat. No.5,527,290 issued to Zadini et al. and U.S. Pat. No. 5,480,388 issued toZadini et al.) and tracheotomies (U.S. Pat. No. 4,556,059 issued toAdamson, Jr.) may have automatic trigger mechanisms that use, a springfor self-propelled insertion. None of the prior art discloses a releasemechanism that controls the depth of penetration of the penetratingmeans inserted at arbitrary speed through arbitrary thickness ofoverlying tissue, against an unknown resistance.

Another problem in employing intraosseous infusion is the need forquickly and easily finding the proper location on a patient's body forinsertion of the infusion tube. A semi-skilled caregiver in an emergencysituation would not be able to quickly identify the target location forintraosseous infusion. Prior art discloses templates for guiding theinsertion of syringes for draining the bursa of the knee and forinsertion of spinal marker needles. A template for guiding a caregiverto the correct location for draining the bursa of the knee along withthe hypodermic needle used in the process is disclosed in U.S. Pat. No.5,364,361, issued to Battenfield. U.S. Pat. No. 4,985,019, issued toMichelson, teaches an X-ray marker disc with a grid pattern and indiciafor determining the location and orientation of the spinal markerneedle. There is a need for a template to guide the placement of anintraosseous infusion apparatus so that a semi-skilled caregiver canaccurately and very quickly determine the site of intraosseous infusion.

A third problem with intraosseous infusion is that strain and stress onthe infusion tube that protrudes above the skin may cause dislodgment ofthe tube from the bone, tearing of the skin or overpenetration of theinfusion tube. One cause of such stress is the movement of skin andtissue which may cause strain on the infusion tube and may dislodge it.The infusion tube may be placed under tension by the intravenous fluidsupply tube. Forces or pressures from objects pressing on theintraosseous infusion site may push the infusion tube too far into orthrough the bone. This problem is particularly difficult when a patientis being transported in an ambulance or in a war zone where movement ofthe patient under uncontrolled conditions is required.

Prior art discloses several devices for supporting catheter tubing, forexample U.S. Pat. No. 4,397,641, issued to Jacobs, which teaches acatheter Support member and U.S. Pat. No. 5,456,671, issued to Bierman,which teaches a catheter anchoring system. Prior art also disclosesseveral protective coverings for the catheter infusion sites as in U.S.Pat. No. 5,074,847, issued to Greenwell et. al., which discloses ashielding device and a method for holding a heparin lock secured to acatheter and U.S. Pat. No 5,449,349, issued to Sallee et al., whichdiscloses an intravenous tubing cover/protector. These supports arecustomized for catheters. Thus, a need for an intraosseous tube supportwhich can create a protective loop of slack, and a protector coveringthe intraosseous infusion site and intraosseous infusion tube exists.

It should therefore be appreciated that there is a significant need foran intraosseous infusion or aspiration apparatus and a related methodthat can be used quickly and easily by even low-skilled caregivers inemergency or field conditions. Further there is needed such a devicethat provides for quick positioning of the target area and one thatenables semi-skilled users to reliably and accurately position anintraosseous infusion device. There is also a need for such a devicethat provides relief from the stress and strain placed on the tubing andprotection against dislodgment or over-penetration.

SUMMARY OF THE INVENTION

According to the invention, there is provided an apparatus forintraosseous fluid infusion and aspiration of bone marrow beneath a bonecortical layer of a patient. The apparatus has an operative end thatrefers to the bone penetrating end of the apparatus and a remote endopposite to the operative end. The apparatus has a housing assemblycomprising inner and outer sleeves, a spring assembly, a bone probeassembly, a release mechanism and a coupler. The housing assembly isoperative to receive a force directly applied by a user. The coupler isoperative to couple the force applied by the user to an infusion tubesuch that the force directly applied by the user drives the infusiontube through the bone. The infusion tube may have a bone portal and ahollow flexible tube affixed to the bone portal. The infusion tubeinfuses fluid to and aspirates tissue from the bone marrow. The releasemechanism removes substantially all of the force directly applied by theuser on the infusion tube once the bone portal has penetrated the bonemarrow a predetermined distance.

The spring assembly is comprised of a spring that is compressed betweenthe remote end of the inner sleeve and the remote end of the bone probeassembly, and functions to hold these two parts in a relative initialposition.

The bone probe assembly is slidable into the housing assembly. As a userexerts force onto the housing assembly, the spring compresses and thebone portal penetrates the bone cortical layer. When the housing iswithdrawn, the infusion tube is left in the body of the patient with thebone portal embedded in the bone marrow and the hollow infusion tubeextending out of the skin.

The housing is, further, comprised of a cylindrical outer sleeve with aball race in an interior surface at the operative end of the sleeve anda cylindrical inner sleeve which is slidably insertable in the outersleeve. The inner sleeve has a plurality of ball holes circumferentiallyspaced in the operative end of the sleeve such that the inner and outersleeve can be coupled through a plurality of balls located partly inthese ball holes and partly in the ball race of the outer sleeve.

Specifically, the bone probe assembly is removably insertable in theinner sleeve. A portion of the outer surface of the bone probe assemblyis conical in shape, decreasing in diameter towards the operative end ofthe infusion apparatus. When a user applies a force to the outer sleeve,the balls couple the outer sleeve to the inner sleeve, which couples theouter sleeve to the infusion tube through a long slender stylet coupledto the remote end of the inner sleeve and over which the hollow infusiontube is mounted. As the user applies force to the outer sleeve, theentire apparatus moves towards the patient and the needles of the boneprobe penetrate the skin and subcutaneous layers until they come to reston the cortical layer. As the user continues to apply force to the outersleeve, all parts of the apparatus, except for the bone probe assembly,continue to move toward the patient and the bone portal begins topenetrate the cortical layer. Because the bone probe assembly is incontact with the cortical layer and is slidable in the inner sleeve, thebone probe assembly does not move toward the patient. As more relativemotion occurs between the bone probe assembly and the rest of theapparatus, the balls start to move down the conical outer surface of thebone probe assembly, and thus move radially inward. When the infusiontube has penetrated the correct distance into the cortical layer, theballs have moved inward until they no longer couple the outer sleeve tothe inner sleeve. This action is the release mechanism which releasesthe outer sleeve from the rest of the apparatus. At this point, anydownward force exerted by the user to the outer sleeve, is nottransferred to the infusion tube, thereby preventing any furtherpenetration of the infusion tube into the bone.

The bone probe assembly is also coupled to the inner sleeve through pinsthat engage pin slots in the inner sleeve. The pin slots allow adisplacement of the bone probe assembly relative to the inner sleevethat is slightly beyond the displacement at which the release mechanismis activated. The pins are located in pin holes in the annular band ofthe bone probe assembly adjacent to the remote end of the conicalsurface down which the balls travel as the release mechanism isactivated. A bone probe ring is adjacent to the operative end of theconical surface. From the bone probe ring, a plurality of needlesproject out in a circle.

Furthermore, the bone probe assembly has an axial opening. In the axialopening there may be an infusion tube surrounded by two support sleevesand mounted on a stylet attached to the inner sleeve and passing throughthe infusion tube and contacting a bone portal. The support sleevesbrace the infusion tube and stylet when a force is applied to the outersleeve. The stylet transfers user applied force to the bone portal tocause it to penetrate the bone.

In another aspect of the invention, a release mechanism is provided.This release mechanism is designed to control the distance over which auser exerted force can act. The displacement of the bone portal relativeto the bone is always identical regardless of the speed at which theforce is exerted by a user, regardless of whether the force exerted by auser is constant or variable, and regardless of the magnitude of theforce exerted on the bone portal. This is in contrast to a springtrigger mechanism where the apparatus is propelled forward by a fixedquantity of energy stored in a spring but the distance propelled cannotbe accurately controlled because the fixed amount of energy stored inthe spring may be either inadequate to penetrate the bone or may be toomuch, resulting in over-penetration of the bone.

In another aspect of the invention, the intraosseous infusion andaspiration apparatus may be optimized for infusion and aspiration ofdifferent bones with different bone resistances, different overlyingskin and subcutaneous resistances, and different depth of penetrationsby modifying several variables. The spring constant, the attributes ofthe bone probe needles, the axial displacement of the balls, the angleof the conical surface on the bone probe assembly, the angle of the ballcontacting surface on the outer sleeve and the size of the pin slots maybe adjusted to yield different bone penetration depths, differentmaximum penetration depths, different applied force, and differentmaximum applied force that would be needed for different bones.

Accordingly, the present invention is embodied in an intraosseousinfusion and aspiration apparatus and related method which effectivelyallows a user to place an infusion tube in the bone marrow of thepatient without having to estimate the penetration depth or bone'sresistance to penetration and without having to estimate the target areaof the placement of the infusion tube. The present invention provides anobject to be positioned, an outer sleeve to push on, a coupler to couplethe outer sleeve to the object being positioned, a position probe thatsenses the location of the object to be positioned relative to areference point and a release mechanism that removes substantially allof the force applied to the object, once the object is correctlypositioned relative to the reference point. More specifically, theobject being positioned is the infusion tube, the coupler is the ballsand the position probe corresponds to the bone probe assembly.

There may be additionally provided an elongated remover in the shape ofa rod that has threads at one end. After an infusion is complete, theremover is inserted into the infusion tube so that it engages thethreads in the bone portal. A force is applied to the remover in thedirection away from the bone thereby extracting the bone portal from thebone.

Another aspect of the invention provides a bone portal (bone-penetratingmember) comprising axially-aligned distal and proximal sections. Theproximal section extends in a distal direction from a proximate end ofthe bone portal and the distal section extends in the distal directionfrom the proximate section to a distal end of the bone portal. The boneportal also comprises a fluid-transport bore extending between aproximal opening in the proximal section and a distal opening in thedistal section. At least a portion of the distal section has across-sectional area, perimeter, diameter and/or dimension greater thanthat of the proximal section.

In another aspect of the invention, there is provided a template patchfor locating the target site for intraosseous infusion and aspiration.The target patch has a curved finger engaging recess and a target zonethat is a predetermined distance from the curved finger engaging recess.The user's finger is used to align the template patch by palpating a keyanatomical of the bone to be infused and engaging the curved fingerengaging recess with the finger of the user so that the target zone ispositioned over the desired area of penetration and infusion.

The template patch serves a second function in relieving strain on theinfusion tube. The flexible template has a tube clamp that can clamp aninfusion tube or a second tube connected to the infusion tube to lessenthe strain and decrease the effect of external forces on the infusiontube. The tube clamp a loop of slack in the flexible infusion tube.Since the underside of the template patch has an adhesive lining, thetemplate patch can be fastened onto the skin of the patient. Theperiphery of the template patch has a fastening material that engageswith a fastening material of a covering that protects the infusion tubefrom dislodgment. The covering may be in the shape of a hard,transparent dome.

In another aspect of the invention, a method for using the intraosseousinfusion and aspiration apparatus may comprise using the template patchto quickly locate the site of infusion by first identifying a keyanatomical feature of the bone to be penetrated. The curved fingerengaging recess of the template patch is engaged with a finger that ispalpating this feature so that the target zone is over the desired areaof penetration. An intraosseous fluid infusion and aspiration apparatusmay be introduced to the target zone and by pushing on the outer sleeveof the apparatus with sufficient force, the bone portal is inserted intothe bone marrow to a predetermined depth. The apparatus may be pulledout after the release mechanism is heard or felt and leaves behind theinfusion tube and the bone portal in the bone. An external tube may beconnected to the infusion tube and then clamped to the tube clamplocated on the template patch to lessen the strain on the infusion tubeor, the infusion tube may be clamped directly in the tube clamp. Acovering may be placed on the template patch to protect the infusionsite. After the infusion is complete, the bone portal and infusion tubemay be removed with a remover that engages the bone portal.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features believed to characterize the invention are set forthin the appended claims. The invention, itself, however, as well as otherfeatures and advantages thereof, will be best understood by reference tothe detailed description which follows, read in conjunction with theaccompanying drawings, wherein:

FIG. 1 is an exploded isometric view of the intraosseous infusion andaspiration apparatus;

FIG. 2A is a perspective view of an infusion tube with the hollowflexible tube, tube connector and bone portal;

FIG. 2B is a perspective view of the bone portal and a portion of theattached hollow tube;

FIG. 2C is a perspective view of the conically tapered bone portal and aportion of the attached hollow tube;

FIG. 3A is a side elevation view of the bone portal;

FIG. 3B is a sectional view of FIG. 3A;

FIG. 3C is a sectional view of the conically tapered bone portal;

FIG. 4 is a cut-away perspective view of the assembled intraosseousinfusion and aspiration apparatus;

FIG. 5 is a sectional view of the intraosseous infusion and aspirationapparatus;

FIG. 6 shows the axial and radial displacement of the ball duringrelease;

FIG. 7 shows the angles on the ball race and the tapered surface of thebone probe assembly in an example of a release mechanism of anintraosseous infusion and aspiration apparatus;

FIG. 8 shows the forces acting on the ball, inner sleeve, and outersleeve during an initial phase of the release mechanism;

FIG. 9 shows the forces acting on the ball, inner sleeve, and outersleeve during a late phase of the release mechanism;

FIG. 10 is the first stage in the use of the intraosseous infusion andaspiration apparatus showing the bone probe against the bone corticallayer and the bone portal just beginning to penetrate the skin;

FIG. 11 is the second stage in the use of the intraosseous infusion andaspiration apparatus showing that the bone portal has penetrated thebone cortical layer;

FIG. 12 is the third stage in the use of the intraosseous infusion andaspiration apparatus showing that the inner sleeve has been releasedfrom the outer sleeve leaving the bone portal at the correct depth inthe bone marrow;

FIG. 13 is the fourth stage in the use of the intraosseous infusion andaspiration apparatus showing that the apparatus has disengaged from theskin of the patient and the infusion tube has been left in the patient;

FIG. 14 shows the placement of the template patch on the skin over thepatient's sternal bone;

FIG. 15 shows the template patch;

FIG. 16 shows the placement of the intraosseous infusion and aspirationapparatus at the target zone of the template patch;

FIG. 17 shows the template patch after the intraosseous infusion andaspiration apparatus has inserted the bone portal into the bone marrowand has been disengaged, and the infusion tube has been connected to theconnector tube;

FIG. 18 shows the covering for the template patch; and

FIG. 19 shows an example of a target patch designed for use at thetibial site for intraosseous infusion.

DETAILED DESCRIPTION WITH REFERENCE TO DRAWINGS

In the following description it is to be understood that the apparatushas two ends: an operative end that refers to the bone penetrating endof the apparatus and the opposite end referred to as the remote end.

The intraosseous infusion and aspiration apparatus 1 serves as anintroducer that introduces an object, an infusion tube 17, to a specificposition and a predetermined depth in the bone marrow 55. The introduceris comprised of an outer sleeve 5, a bone probe assembly 3, and acoupler 7 that couples the infusion tube 17 to the outer sleeve 5. Thusthe infusion tube 17 is positioned in the bone marrow 55 through theaction of an outer sleeve 5, a bone probe assembly 3 that senses thelocation of the infusion tube 17 that is being positioned, and a coupler7 that couples the outer sleeve 5 to the infusion tube 17 so that forceexerted on the outer sleeve 5 is transferred to the infusion tube 17.The automatic release mechanism of the apparatus involves all partsexcept for the infusion tube 17.

A cross-section of the intraosseous infusion and aspiration apparatus 1is shown in its preferred embodiment in FIG. 1. The apparatus has ahousing assembly 2, a plurality of balls 7, a spring assembly 8, astylet 50, stylet mount 48, stylet base 14 and a bone probe assembly 3.

The housing assembly 2 has an outer sleeve 5 and an inner sleeve 6. Thehollow outer sleeve 5 is cylindrical in shape and serves as the surfaceto which force is applied. A ball race 9 is formed in the interior wallof the operative end of the hollow outer sleeve 5. The hollow outersleeve 5 also has a cap 16 with a projection or thread that allows it tofit snugly into the remote end of outer sleeve 5.

The inner sleeve 6, also of cylindrical shape and hollow, slidably fitsinside the hollow outer sleeve 5. The inner sleeve 6 has a plurality ofball holes 10 circular in shape and a plurality of elongated pin slots11 circumferentially spaced about the operative end of the inner sleeve6.

A plurality of balls 7 serve as the coupler coupling the outer sleeve 5to the infusion tube 17. The balls 7 couple the outer sleeve 5, to theinner sleeve 6 which is releasably attached to the infusion tube 17. Theballs 7 are of a diameter slightly smaller than the ball holes 10 andfit partly in the ball holes 10 of the inner sleeve 6 and partly in theball race 9 of the hollow outer sleeve 5 coupling the hollow outersleeve 5 with the inner sleeve 6.

The spring assembly 8 has a helical spring 13 which is positioned insidethe inner sleeve 6, abutting a stylet base 14. One side of the styletbase 14 abuts a retaining lip 15 of the interior of the inner sleeve 6proximate a remote end thereof. On the opposite side, the stylet base 14has a projection that fits snugly into the remote end of the spring 13.The stylet base 14 couples the compression forces from spring 13 to theinner sleeve 6.

A stylet 50 is connected to a stylet mount 48 (see FIG. 5) affixed tothe center of the stylet base 14. Stylet base 14 is coupled to the innersleeve 6 and the spring 13. The force exerted onto the hollow outersleeve 5 is transferred to the inner sleeve 6 through the balls 7coupling the two bodies 5, 6 together and is further transferred to thespring 13 and stylet 50 through the retaining lip 15 and stylet base 14.The stylet 50 is rigid and is inserted into the infusion tube 17 to pushthe infusion tube 17 into the bone 40.

Infusion tube 17 consists of flexible tubing 18 and bone portal 21 (i.e.bone-penetrating member 21). Flexible tubing 18 is a hollow, elongated,flexible tube connected to a tube connector 20. (FIG. 2A) at its remoteend. Referring to FIGS. 2A and 2B, flexible tubing 18 is connected tobone portal 21. Flexible tubing 18 is attached to bone portal 21providing a fluid passageway from flexible tube 18 to bone portal 21.Referring to FIGS. 2A, 2B, 2C, 3A, 3B and 3C, bone portal 21 is made ofa rigid material such as stainless steel and has a fluid-transport bore66 which communicates between distal and proximal openings 101, 102 toallow the infusion of fluid from tubing 18 into the bone marrow. In theillustrated embodiments of FIGS. 2C, 3A, 3B, 3C, bone-penetrating member21 comprises a proximate section 103 which extends in a distal directionfrom a proximate end 104 of bone portal 21 and a distal section 105which extends in the distal direction from proximate section 103 to adistal end 106 of bone portal 21. At least a portion 107 of distalsection 105 may have a cross-sectional area, perimeter and/or diametergreater than that of proximate section 103. Portion 107 may have anouter surface that is tapered to extend transversely outwardly as itextends in the distal direction. Portion 107 may have an outer surfacethat is frustroconically shaped. On the interior surface of bore 66 arethreads 22. An annular shoulder 60 serves as a stop for tubing 18 thatis attached to the exterior surface of the bone portal 21. Proximal end104 of bone portal 21 may be beveled to form one or more sharp points 62which may be spaced apart from an axial center of bone-penetratingmember 21 and which may be arranged around proximal opening 102.Alternatively, as seen in FIGS. 2C and 3C, proximal end 104 of boneportal 21 b may be conically tapered. Bone-penetrating member 21 maycomprise a force-receiving surface 108 for operatively coupling tostylet 50 to allow force to be transmitted from stylet 50 to bone portal21.

As seen in FIG. 1, the remover 23 has a slender rod threaded at its endwith threads 68 dimensioned to register with the threads 22 on theinterior bore of the bone portal 21 and a handle 25 at the remote end isused to remove the flexible tubing 18 and bone portal 21 from the bonemarrow after the infusion is complete.

Referring to FIG. 1, the intraosseous infusion and aspiration apparatus1 further includes a bone probe assembly 3 that serves as a positionprobe allowing the location of the object, the infusion tube 17, to bepositioned relative to a reference point. The bone probe assembly 3comprises a bone probe ring 4, a plurality of pins 28, and a pluralityof needles 31. The bone probe ring 4 comprises an annular band 26 thatis dimensioned to slide into one end of the inner sleeve 6. This annularband 26 of the bone probe ring 4 has a plurality of pin holes 27. Aplurality of pins 28 can be put through these pin holes 27 and into theelongated pin slots 11 in the inner sleeve 6 further slidably securingthe bone probe assembly 3 to the inner sleeve 6. The bone probe ring 4also has a conical surface 29 (a ramp in transverse drawings) adjacentto the annular band 26. A ring of needles 31 protrude out from theoperative end 30 of bone probe ring 4. There is a protective covering 32that covers the needles 31 to protect an administrator from accidentalcontact with the needles 31.

The bone probe needles 31 serve as a reference for the measurement ofthe distance through the bone that the bone portal 21 has penetratedsince the needles 31 penetrate the skin and subcutaneous layersoverlying the bone, but do not penetrate the bone.

The intraosseous infusion and aspiration apparatus 1 further includeslongitudinally split support sleeves 33 located in the bore of the boneprobe ring 4. Support sleeves 33 brace the stylet 50 so that it does notbuckle under the force applied to it to penetrate the bone.

Referring to FIG. 4, the assembled intraosseous infusion and aspirationapparatus 1 is shown in its position before use with a protectivecovering 32 over the bone probe needles 31.

The intraosseous infusion and aspiration apparatus 1 can be optimizedfor infusion of different bones such as the sternum, the proximal anddistal ends of the tibia, the femur, and the clavicle. These bones havedifferent resistances to penetration thus the amount of force needed toinsert the apparatus in the bone marrow of the bones may differ. Also,since different depths of penetration of bone to reach the bone marrowmay be needed for different bones, the bone penetration distance of thebone portal may need to be adjusted. In addition, the skin andsubcutaneous layers overlying the different bones may differ inthickness and their resistance to penetration. The bone probe ring 4 andspring 13 may have to be adjusted to compensate for these changes in thethickness and resistance of the skin and underlying tissue. Theintraosseous infusion and aspiration apparatus 1 may also be customizedfor pediatric patients who usually have smaller bones with lesserresistance to penetration.

One feature of the intraosseous infusion and aspiration apparatus 1 thatcan be adjusted is the spring force applied to the bone probe ring 4.The tips of the bone probe needles 31 serve as a reference point todetermine the depth of penetration of the bone portal 21 through thecortical bone layer 40 and bone marrow 55. The magnitude of the springforce needed to force the bone probe needles 31 to penetrate the skin 56and subcutaneous layer 57 so that it abuts the bone cortical layer 40 isdependent on the bone probe needle 31 configuration, the type of tips ofneedles 31, the size and the number of needles 31, and the resistance ofthe skin 56 and subcutaneous layer 57. For example, if the number ofneedles is decreased then a weaker spring force may be used for the boneprobe needles 31 to penetrate the same skin and underlying tissue. Sincedifferent anatomical sites have different resistances in the skin andunderlying tissues, the spring force and the bone probe needles 31 canbe adjusted to obtain optimum characteristics for the penetration of thebone probe needles 31 to the cortical bone 40.

Another feature of the apparatus 1 that can be adapted is the releasemechanism. Referring to FIG. 5, the ball release mechanism comprises aplurality of balls 7, the ball race 9, the ball holes 10, the springassembly 8 and the conical surface 29 of the bone probe ring 4 and thebone probe assembly 3 itself. Referring to FIG. 6, the starting positionof the ball 7 before release is on the remote end and the endingposition of the ball 7 is proximate the operative end of the conicalsurface 29 of the bone probe ring 4.

Referring to FIG. 7, the angle of the conical surface 29 on the boneprobe ring 4, the angle of the ball contacting surface 49 of the ballrace 9 and the spring force can be adjusted to determine the maximumbone portal penetration force available to insert the infusion tube 17to a predetermined depth. For example, if the angle of the conicalsurface with the axis of the bone probe assembly 4 (see FIG. 7) isincreased for a constant ball race contacting surface angle 8 andconstant spring constant, the maximum available bone portal penetrationforce will decrease. If the angle 8 is increased as angle θ and thespring constant are kept constant, the maximum available bone portalpenetration force will increase. If the spring constant is increased forconstant angle θ and angle Φ, the maximum available bone portal forcewill increase. If this maximum bone portal force is exceeded, theapparatus 1 is released without damage. Since this force is much lessthan the force at which mechanical failure occurs, the apparatus willnot be damaged and the patient will not be injured.

FIG. 8 shows the forces on the ball release mechanism in an initialphase where the ball is positioned at the remote end of the conicalsurface 29 of the bone probe ring 4. In this initial phase, forces up tothe maximum force may be applied without premature release. FIG. 9 showsthe forces on the ball release mechanism as the balls are positioned inthe operative end of the conical surface 29 of the bone probe ring 4. Inthis late phase, the apparatus 1 may release prematurely since there isa greater horizontal force acting on the ball 7 forcing the ball 7 ontothe ramp 29. The horizontal force tends to push the bone probe up andcauses release. In this phase, the axial displacement of the boneassembly relative to the inner sleeve 6 is determined by the angle Φ,the angle θ and the diameter of the balls 7. Changing one of thesedesign variables will change the axial displacement that occurs in thisphase.

Another aspect of the intraosseous infusion and aspiration apparatus 1that can be adjusted is the size of elongated pin slots 11 (see FIG.10-13) in the inner sleeve 6 proximate the operative end. These pinslots 11 determine the maximum axial displacement of the bone probeassembly 3 in relation to the inner sleeve 6. Because the infusion tube17 is coupled to the inner sleeve 6, these pin slots 11 also determinethe maximum penetration depth of the infusion tube 17 in relation to thebone probe needles 31. Thus, if there is a failure in the releasemechanism, this feature ensures that the bone portal 21 does notover-penetrate the bone marrow and cause injury to the patient.

The ball race 9 allows for rotational decoupling between the hollowouter sleeve 5 and the inner sleeve 6 optionally, ball race sectionscould be provided in order to provide limited decoupling between thehollow outer sleeve 5 and the inner sleeve 6. With such a feature, ifthe needles 31 were decoupled by use of a bearing on the bone probeassembly for example, it would be possible to apply torque to the boneportal 21 in order to assist its penetration into the bone.Alternatively, other methods may be used to couple the outer sleeve 5 tothe inner sleeve 6, such as a pin in outer sleeve 5, engaging a slot ofinner sleeve 6.

The operation of the intraosseous infusion and aspiration apparatus 1and its release mechanism is shown in FIG. 10, 11, 12, 13. The apparatus1 contains a release mechanism for disconnecting the infusion tube 17and the bone portal 21 from the outer sleeve 5 when the bone portal 21is at a specific depth relative to the outer surface of the corticalbone 40 thereby preventing the bone portal 21 from penetrating beyondthe bone marrow 55 and out the opposite cortical layer of the bone.Specifically, the intraosseous infusion and aspiration apparatus 1 isplaced on the target location perpendicular to the skin of the patient.A force is applied so that the bone probe needles 31 go through the skin56. A portion of the bone portal 21 also enters the subcutaneous layer57 (see FIG. 10).

Referring to FIG. 10, the balls 7 are in the ball holes 10 and ball race9. The pins 28 sit at the operative end of the elongated pin slots 11.As more force is applied on the hollow outer sleeve 5, as seen in FIG.11, the outer sleeve 5 and the inner sleeve 6 move towards the operativeend of the apparatus 1. Since the infusion tube 17 is coupled throughthe stylet 50 to the stylet base 14 which is coupled to the inner sleeve6 which in turn is coupled to the outer sleeve 5, as force is exerted onouter sleeve 5, the bone portal 21 penetrates the bone cortical layer40. Since the bone probe assembly 3 has not changed in position, thereis relative movement of the pins 28 on the bone probe assembly 3 towardsthe remote end of the elongated pin slots 11 of the inner sleeve 6. Theballs 7 coupling the inner sleeve 6 to the hollow outer sleeve 5 areallowed to move out of the ball race 9 of the hollow outer sleeve 5 andthrough the ball holes 10 in the inner sleeve 6 toward the center of theapparatus since the hollow outer sleeve 5 is moving down relative to thebone probe assembly 3 and space is created into which the balls 7 canmove.

As seen in FIG. 12, as more force is applied, the penetration of theinfusion tube 17 into the bone marrow 55 takes place. Eventually theballs 7 have traveled radially inward towards the centre of theapparatus sufficiently so that they no longer make contact with the rampsurface 49 of the ball race 9 in the outer sleeve 5. When this occurs(see FIG. 12) force is no longer transferred from the outer sleeve 5 tothe inner sleeve 6. At this point, the infusion tube 17 has beenreleased from its coupling to the outer sleeve 5. The infusion tube 17has been inserted to the correct depth.

The hollow outer sleeve 5 has been pushed so that the operative end ofthe hollow outer sleeve 5 rests on the skin of the patient. The balls 7have moved out of the ball race 9, through the ball holes 10, and downthe conical surface 29 into the space between the bone probe assembly 3and the inner sleeve 6, uncoupling the hollow outer sleeve 5 from theinner sleeve 6. Compressed spring 13 exerts a force on the bone probeassembly 3 against the stylet base 14 causing the balls 7 to be pressedoutwardly against the outer sleeve 5, thereby producing a frictionalforce between the outer sleeve 5, the inner sleeve 6 and the bone probeassembly 3. In FIG. 13, the hollow outer sleeve 5 is pulled back,pulling the stylet 50 from the infusion tube 17. The support sleeves 33fall out as the apparatus 1 is removed. The infusion tube 17 can beconnected to another tube 41 or directly to a source of drugs and fluidusing the tube connector 20 on the infusion tube 17.

This intraosseous infusion and aspiration apparatus 1 can be used inconjunction with a target/strain-relief patch 34 (FIG. 14). The patch 34is used as a guide to ensure that the intraosseous infusion andaspiration apparatus 1 is correctly positioned in the proper location ona bone. A prominent anatomical feature of the bone like a notch, adepression, or a bump is used as a reference point to determine thetarget location for the infusion or aspiration of the bone marrow offlat bones such as the sternum, or iliac crest and long bones such asthe femur, the tibia, or the radius.

Referring to FIG. 14, the patch 34 includes a patch base 47 which isused to locate a target zone 37 on the manubrium bone of a patient byplacing the finger in peripheral notch 35 and at the same time locatingthe finger in the sternal notch 36 of the patient. Referring to FIG. 15,a target zone 37 in the patch base 47 is positioned a predetermineddistance away from the peripheral notch 35. The target zone 37 is usedto align the intraosseous infusion and aspiration apparatus 1 with adesired area of penetration of the patient. Also, the patch base 47 hasan adhesive underside with a liner 58 that can be peeled to removablyfasten the patch base 47 to the skin 56 of the patient. Liner 58 may besplit such that it has two pieces that can be removed independent of oneanother. See, for example, FIG. 17 which shows liner 58 made up of afirst piece 58A and second piece 58B.

In addition, a fastening material 38 is present around the periphery ofthe patch base 47 so that a cover 44 may be placed on it and engage thefastening material 45 (FIG. 18). The patch 34 also has a tube clamp 39outside the fastening material 45 on an extension of the patch base 47.The infusion tube 17 may be attached by the tube clamp 39 to the patch34 and then connected to an intravenous tube through its tube connector20. In another embodiment, a connector tube 41 with a connector 42 and aconnector 43 is attached to the tube clamp 39. Connector tube 41 isattached to the tube connector 20 on the infusion tube 17 with connector42, and connector 43 is used to attach connector tube 41 to a source offluids. The tube clamp 39 or the connector tube 41 decreases the strainon the bone portal 21 by creating the slack in the tube and also preventthe accidental dislodgment of the infusion tube 17 and the bone portal21 by either clamping the infusion tube 17 or the connector tube 41 tothe patch base 47.

Referring to FIG. 16, the intraosseous infusion and aspiration apparatus1 is placed perpendicular to the patch 34 in the target zone 37. Afterthe bone portal 21 has been inserted into the bone marrow and theintraosseous infusion and aspiration apparatus 1 removed, the infusiontube 17 is connected to the connector tube 41 with the tube connector 20and connector 42 as shown in FIG. 17. Connector 43 of the connector tube41 can be connected to a source of intravenous drugs or fluid.

FIG. 18 shows a preferred embodiment of the cover 44 which has a dome 46of transparent material with fastening material 45 around its periphery.The dome 46 can be placed on the patch base 47 and the fasteningmaterial 38 of the patch base 47 can engage with the fastening material45 of the cover 44 to protect the site of infusion. The fasteningmaterials can be hook and loop which allows the dome to be removed andreattached.

The intraosseous infusion and aspiration apparatus 1 can be used aloneif a patch 34 is not available, or in conjunction with the patch 34. Thepatch 34 may also be used with other intraosseous infusion andaspiration apparatus. When a patch 34 is used in conjunction with theintraosseous infusion apparatus 1, the top half of the backing of thepatch 34 is first removed to expose the adhesive lining on theunderside. An appropriate anatomical marker on the appropriate bone islocated, for example the sternal notch 36 in the manubrium bone of thepatient. An index finger is placed on the anatomical markerperpendicular to the surface of the bone and the peripheral notch 35 onthe patch 34 is arranged around the finger in the proper orientation. Inthis example, the peripheral notch 35 and the target zone 37 are overthe patient's midline on the chest. The top half of the patch 34 ispressed onto the skin and the rest of the backing is removed to exposethe rest of the adhesive lining that secures the patch 34 to the skin ofthe patient.

The bone probe needles 31 protective covering 32 is removed, and thebone probe needles 31 are placed on the target zone 37 with the axis ofthe apparatus 1 perpendicular to the skin of the patient. The hollowouter sleeve 5 is pushed into the target zone 37 until the release ofthe hollow outer sleeve 5 from the inner sleeve 6 is heard and felt. Thehollow outer sleeve 5 is pulled straight back. The support sleeves 33fall out leaving the infusion tube 17 with bone portal 21 embedded inthe patient. A syringe is attached to the infusion tube 17 to withdrawmarrow to verify that the infusion tube 17 is at the correct depth inthe bone. The bone probe needles 31 protective covering 32 is put backon the apparatus 1 for safety reasons. The infusion tube 17 is connectedto a connector tube 41 attached at the patch 34 through the tubeconnector 20 to provide slack in the tubing and less strain on theinfusion site. The connector tube 41 is connected to a supply ofintravenous drugs or fluid. The protective cover 44 is placed on thepatch 34 so as to engage the covering fastening material 45 with thepatch fastening material 38, protecting the infusion tube 17 fromdislodgement. After the infusion is complete, the infusion tube 17 maybe removed by inserting a remover 23 into the infusion tube 17 andturning it clockwise to engage the threads in the bone portal 21 untilthe remover stops turning. The remover is then pulled straight outremoving the infusion tube 17 from the patient.

As an example of the specifications of the apparatus 1 used to infusethe manubrium the following represent a possible design:

Bone probe needles: Ten 1.27 mm hypodermic needles equi-spaced aroundthe bone probe.

-   -   angle Φ=15 degrees    -   angle θ=60 degrees    -   Ball radius=3.16 mm    -   Maximum force on spring=9.1 kg    -   Activation distance of bone portal relative to end of bone probe        needles=8.87 mm

Referring to FIG. 19, a tibial target patch 51 designed for use at thetibial site for intraosseous infusion is shown. This is a site commonlyused in children, and occasionally used in adult patients. The tibialsite target patch 51 has an alignment feature 52 that is aligned withthe tibial tuberosity at the proximal end of the tibia. The tibialtarget patch 51 has a marking 53 on it for aligning with the ridge ofbone that can be felt along the axis of the tibia. The tibial targetpatch 51 has an adhesive backing with a liner that is removed to placethe patch on the skin. The tibial target patch 51 has a tibial targetzone 54 that is used as a target for placing any intraosseous needle.This invention removes the need for judging the distances from theanatomical landmarks. The patch could also have an instrument guide (notshown) that guides the needle into the bone at the recommended angle of45 degrees. The patch could also have loop fasteners for attaching aprotective dome designed for placement at this site. The patch couldalso have a connector tubing bonded to the patch to remove stress andtrain from the infusion tube or needle. A similar target patch caneasily be envisioned for use at other target sites, for example thedistal end of the tibia, near the ankle; the distal end of the femurnear the knee; the iliac crest site; or the distal end of the radius(lower arm).

What is claimed is:
 1. An apparatus for intraosseous fluid infusion or aspiration of bone marrow of a subject, the apparatus comprising: (a) a bone probe assembly having a plurality of bone probes for penetrating a soft tissue and resting on a surface of a cortical layer of a bone; (b) a bone penetrating device having a distal end and a pusher at a proximal end for transmitting a force to push the distal end of the bone penetrating device to penetrate into said bone; wherein the bone penetrating device is slidably movable relative to the bone probe assembly.
 2. An apparatus according to claim 1, wherein the bone probe assembly comprises an aperture and the bone penetrating device is slidably movable through said aperture relative to the bone probe assembly.
 3. An apparatus according to claim 2, wherein said aperture is located at an axial center of the bone probe assembly.
 4. An apparatus according to claim 1, wherein the plurality of bone probes are located on a circle surrounding an axial center of the bone probe assembly.
 5. An apparatus according to claim 1, wherein the number of bone probes is in the range of 3 to
 12. 6. An apparatus according to claim 1, wherein the bone penetrating device comprises a stop surface and the slidable movement of the bone penetrating device relative to the bone probe assembly is limited by said stop surface.
 7. An apparatus according to claim 1, wherein the pusher of the bone penetrating device moves in the same direction as the distal end of the bone penetrating device when the bone penetrating device is slidably moved relative to the bone probe assembly towards the subject.
 8. An apparatus according to claim 1, wherein the bone probe assembly comprises a body portion and the plurality of bone probes extend from the body portion.
 9. An apparatus according to claim 1, wherein the plurality of bone probes comprise a plurality of needles.
 10. An apparatus according to claim 1, further comprising a patch for guiding the bone probe assembly to be located to a target zone on a body surface of the subject.
 11. An apparatus according to claim 10, wherein the patch comprises a patch base and an indicia located on or at an edge of the patch for locating the patch to said target zone.
 12. An apparatus according to claim 11, wherein the indicia comprises a notch.
 13. An apparatus according to claim 12, wherein the notch has a shape that generally matches an anatomical feature of the subject.
 14. An apparatus according to claim 12, wherein the notch has a shape that generally matches a sternal notch on a manubrium bone of the subject.
 15. An apparatus according to claim 10, wherein the patch comprises an opening formed in the patch base at a predetermined location relative to the indicia.
 16. An apparatus according to claim 15, wherein a distance of the notch to the opening is shorter than a distance of any other peripheral portion of the patch to the opening.
 17. An apparatus according to claim 10, comprising a tube clamp affixed to the patch base for grippingly engaging a tube to the patch base.
 18. An apparatus according to claim 10, wherein the patch is flexible.
 19. An apparatus according to claim 10, wherein the patch has an adhesive underside.
 20. An apparatus according to claim 1, wherein the distal end of the bone penetrating device comprises a bone portal.
 21. An apparatus according to claim 20, wherein the bone portal comprises a bore extending therethrough.
 22. An apparatus according to claim 20, wherein the bone penetrating device comprises an infusion tube coupled to the bone portal.
 23. An apparatus according to claim 22, wherein the bone penetrating device comprises a stylet extending through the infusion tube and the bore of the bone portal.
 24. An apparatus according to claim 23, wherein the stylet is removable from the infusion tube and the bone portal. 